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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intravenous catheter force-activated separation device.
Definition An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.
Product CodeQOI
Regulation Number 880.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
LINEAR HEALTH SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
LINEAR HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
LINEUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
LINEUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SITE SAVER, INC. D/B/A LINEUS MEDICAL
  GRANTED 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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